Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-13 @ 6:46 PM
Study NCT ID:
NCT02960412
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2016-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-05-23', 'releaseDate': '2019-04-29'}], 'estimatedResultsFirstSubmitDate': '2019-04-29'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to ureteral patency', 'timeFrame': 'intra-operative', 'description': 'time to confirmation of ureteral patency in seconds'}], 'secondaryOutcomes': [{'measure': 'adverse effects from furosemide administration', 'timeFrame': 'immediately post operative (1-3 days post operatively)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystoscopy']}, 'referencesModule': {'references': [{'pmid': '30870291', 'type': 'DERIVED', 'citation': 'Patton S, Tanner JP, Prieto I, Jackson E, Greene K, Bassaly R, Wyman AM. Furosemide Use and Time to Confirmation of Ureteral Patency During Intraoperative Cystoscopy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):669-674. doi: 10.1097/AOG.0000000000003155.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.', 'detailedDescription': 'Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.\n\nThe time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing any urogynecologic surgery\n* No allergy or contraindication to receiving furosemide\n* Normal Creatinine/glomerular filtration rate\n\nExclusion Criteria:\n\n* Unable to consent, including if non English speaking\n* Allergy or contraindication to receiving furosemide\n* Intraoperative injury to the lower urinary tract'}, 'identificationModule': {'nctId': 'NCT02960412', 'briefTitle': 'Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Randomized Controlled Trial Evaluating Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy', 'orgStudyIdInfo': {'id': 'Pro00026976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'furosemide', 'description': 'furosemide 10mg (1mL) IV push for one dose', 'interventionNames': ['Drug: furosemide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'normal saline 1mL IV push for one dose', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'furosemide', 'type': 'DRUG', 'otherNames': ['Lasix'], 'description': '10mg lasix given intraoperatively', 'armGroupLabels': ['furosemide']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal saline given intraoperatively as placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-04-29', 'type': 'RELEASE'}, {'date': '2019-05-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of South Florida'}}}}